FDA.reportPublic FDA data

PMA P040027S058

Device
GORE VIATORR TIPS Endoprosthesis
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040027
Supplement
S058
Product code
MIR
Decision date
2017-09-27
Classification
Shunt, Portosystemic, Endoprosthesis
Generic name
SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Approval order statement
Additional supplier of films used in the manufacturing of the GORE EXCLUDER AAA Endoprosthesis, GORE VIATORR TIPS Endoprosthesis, GORE TAG Thoracic Endoprosthesis, GORE CARDIOFORM Septal Occluder, and GORE VIABHAN Endoprosthesis with and without Heparin Bioactive Surface.

Current openFDA PMA Record#

Device
GORE VIATORR TIPS Endoprosthesis
Applicant
W. L. Gore & Associates, Inc.
PMA number
P040027
Supplement
S058
Product code
MIR
Generic name
SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
Decision date
2017-09-27
Decision code
OK30
Date received
2017-08-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Additional supplier of films used in the manufacturing of the GORE EXCLUDER AAA Endoprosthesis, GORE VIATORR TIPS Endoprosthesis, GORE TAG Thoracic Endoprosthesis, GORE CARDIOFORM Septal Occluder, and GORE VIABHAN Endoprosthesis with and without Heparin Bioactive Surface.